Identification of oxidative degradation impurities of Olanzapine drug substance as well as drug product
Impurities found in stressed and stability studies of Olanzapine (polymorphic form-I) [1–7] in both drug substance and drug product are described. These impurities are identified as 4-(4-methyl-1-piperazinyl)-3-hydroxymethylidene-1 H-benzo[b][1,4]diazepine-2(3H)-thione (hydroxymethylidene thione) an...
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Published in | Journal of pharmaceutical and biomedical analysis Vol. 56; no. 2; pp. 413 - 418 |
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Main Authors | , , , , , , |
Format | Journal Article |
Language | English |
Published |
Amsterdam
Elsevier B.V
10.09.2011
Elsevier |
Subjects | |
Online Access | Get full text |
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Summary: | Impurities found in stressed and stability studies of Olanzapine (polymorphic form-I)
[1–7] in both drug substance and drug product are described. These impurities are identified as 4-(4-methyl-1-piperazinyl)-3-hydroxymethylidene-1
H-benzo[b][1,4]diazepine-2(3H)-thione (hydroxymethylidene thione) and (Z)-4-(4-methyl-1-piperazinyl)-3-acetoxymethylidene-1
H-benzo[b][1,4]diazapine-2(3H)-thione (acetoxymethylidene thione). An oxidative degradation pathway of Olanzapine, for the formation of these impurities, has been proposed. |
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Bibliography: | http://dx.doi.org/10.1016/j.jpba.2011.05.003 ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 |
ISSN: | 0731-7085 1873-264X |
DOI: | 10.1016/j.jpba.2011.05.003 |